Focal radiation dose escalation in patients with primary prostate cancer (HypoFocal) – a prospective, multicenter, non-randomized study with 2 arms / Accompanying translational project: PersoRad

Focal radiation dose escalation in patients with primary prostate cancer (HypoFocal) – a prospective, multicenter, non-randomized study with 2 arms / Accompanying translational project: PersoRad - HypoFocal - Phase II

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017570

Enrollment

130

Registered

2019-08-23

Start date

2019-07-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Intensity Modulated Radiation Therapy (IMRT) Group 2: Brachytherapy (HDR)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Histology proven PCA; - cT1b-3b, cN0 and cM0 (MRI, PET/CT); - Intermediate and high risk; - ECOG Performance Status 0 or 1; - IPSS < 15; - size of prostate gland = 60 ml (after concluding neoadjuvant ADT)

Exclusion criteria

Exclusion criteria: - cT4 (MRT or PET/CT); - Gleason = 9; - Neuroendocrine tumors; - PSA > 40 ng/ml; - Contraindications for MRI; - Other malignancies (tumors that have not been healed); - Fluorides, inflammatory bowel disease; - Previous TURP or surgery of the prostate; - Patient not legally competent; - Previous radiation in the pelvic area

Design outcomes

Primary

Measure	Time frame
Assessment of acute and chronic toxicities, as well as quality of life 2 years after treatment	—

Secondary

Measure	Time frame
- 2 and 5 years' biochemical control according to Phoenix criteria (1); - Assessment of chronic toxicity and quality of life (5 years after treatment); - Assessment of overall survival, PCa specific survival and survival without metastases after 5 years; - Assessment of rate and localization of recurrences after 2 and 5 years (defined by MRI, PSMA PET/CT and/or biopsy); - Rate of screened patients as related to rate of actually included patients and adherence to dose restrictions; - Initiation of a phase 3 study; - Translational project PersoRad: Quantification of intrinsic radiosensitivity, correlation with clinical parameters, assessment of patients' personal preferences and quality of life, implementation in radiobiological model systems.	—

Measure

Time frame

- 2 and 5 years' biochemical control according to Phoenix criteria (1); - Assessment of chronic toxicity and quality of life (5 years after treatment); - Assessment of overall survival, PCa specific survival and survival without metastases after 5 years; - Assessment of rate and localization of recurrences after 2 and 5 years (defined by MRI, PSMA PET/CT and/or biopsy); - Rate of screened patients as related to rate of actually included patients and adherence to dose restrictions; - Initiation of a phase 3 study; - Translational project PersoRad: Quantification of intrinsic radiosensitivity, correlation with clinical parameters, assessment of patients' personal preferences and quality of life, implementation in radiobiological model systems.

—

Countries

Germany

Contacts

Public ContactConstantinos Zamboglou

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

constantinos.zamboglou@uniklinik-freiburg.de+49 761 270-94610

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026